The Recall Desk
HighFDA (Devices)·Z-2300-2021·Announced 2021-08-25

IV Catheters Recalled Due to Possible Missing Sterility

Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving an invasive device (IV catheter) where sterilization defects create a potential infection risk. No illnesses or injuries have been reported, placing it in the High category per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Delta Med SpA is recalling the NEO DELTA Self Safe 1 IV catheter (REF 3708122, Lot 00A1160627) due to sterilization defects. The company has identified problems related to sterilization processes that may have resulted in missing sterility on affected units.

This recall affects approximately 5,000 units that were distributed in Florida and Minnesota. IV catheters that are not properly sterilized may pose a risk of infection when inserted into patients.

Patients or healthcare providers who have these catheters in inventory should discontinue use immediately. Contact Delta Med SpA or your healthcare provider for information about returning or disposing of affected units safely.

The recalled product

Product
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Manufacturer
Delta Med SpA
Category
Medical Device — IV Catheter
Hazard
  • missing-sterility
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • REF 3708122
  • Lot 00A1160627

Distribution

Distributed nationwide across the United States.

Related recalls

Same category